FDA — authorised 24 September 2009
- Application: NDA022468
- Marketing authorisation holder: ACROTECH BIOPHARMA
- Local brand name: FOLOTYN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Folotyn in United States
FDA authorised Folotyn on 24 September 2009
Marketing authorisation
Folotyn in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Folotyn approved in United States?
Yes. FDA authorised it on 24 September 2009.
Who is the marketing authorisation holder for Folotyn in United States?
ACROTECH BIOPHARMA holds the US marketing authorisation.